Evaluation of Patients With Immune Function Abnormalities

Verified September 12, 2017 by National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) )

Sponsor:

National Institute of Allergy and Infectious Diseases (NIAID)

ClinicalTrials.gov Identifier:

NCT00128973

First Posted: August 10, 2005

Last Update Posted: October 19, 2017

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This study will evaluate patients with abnormal immune function that results in recurrent or unusual infections or chronic inflammation. This may include inherited conditions, such as X-linked severe combined immunodeficiency (XSCID), chronic granulomatous disease (CGD), and leukocyte adhesion deficiency (LAD), or conditions resulting from outside factors, such as graft-versus-host disease (GVHD). The information from this study will be used to establish the pattern and pace of change of the disease and to help develop new treatments. The period of observation and study following enrollment in this study may be for up to one year. In addition these studies may provide the medical information needed to determine eligibility for enrollment in other clinical study protocols and more prolonged follow up.

Patients of any age with abnormal immune function who have recurrent or unusual infections, whose blood tests show evidence of immune dysfunction, or who have GVHD, XSCID, CGD or LAD may be eligible for this study. Patients' parents, siblings, grandparents, children, aunts, uncles and first cousins of any age also may be included. Healthy normal volunteers between 18 and 85 years of age are recruited as controls.

Normal volunteers undergo a physical examination and provide blood, saliva, and urine samples for immune function studies. Patients' family members provide a medical history, have a physical examination, and give blood and urine samples, and possibly a saliva sample. The samples are used for genetic and routine laboratory studies. Investigators may request tissue samples, such as biopsy specimens, previously removed for medical reasons to be sent to NIH for study. Patients undergo the following tests and procedures:

Medical history and physical examination.

Blood and urine tests, including analysis for genes involved in immune disorders.

Buccal smear (in some patients) for genetic studies. This involves scraping the lining of the mouth near the cheek.

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Ages Eligible for Study:

up to 90 Years (Child, Adult, Senior)

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Criteria

INCLUSION CRITERIA:

Patients:

Patients with abnormalities of immune function as manifested by recurrent or unusual infections, recurrent or chronic inflammation, or previous laboratory evidence of immune dysfunction are eligible for screening and baseline assessment under this protocol.

- Already be enrolled and eligible to participate on protocol #05-I-0213 Screening and Baseline Assessment of Patients with

Abnormalities of Immune Function

- Be at least 8 years old

Must have clinical evidence for significant life-threatening infection that would be a standard of care medical indication for diagnostic CT scan where the FDG PET-CT/MR-PET scan would be performed in lieu of that indicated diagnostic CT; or have had a CT or MRI that did not adequately indicate the anatomic extent, location(s) or intensity of the infection

Must be capable of overnight fasting and stopping of any intravenous glucose or other intravenous nutritional feeding for at least 12 hours before the FDG injection and through the period of time required for the FDG PET-CT/MR-PET scans, because glucose and insulin significantly inhibits uptake of FDG.

Must be psychologically capable of remaining in the confined space of the PET-CT and MR-PET instruments. Patient will remain eligible for FDG PET-CT alone if the subject cannot tolerate the confines of the MR-PET instrument.

Have cancer or have had radiation or chemotherapy to treat a cancer in the past 5 years.

Have diabetes or abnormal glucose tolerance.

Weigh more than 299lbs (or 136kg) or cannot fit in the bore of the instruments.

Are a women of childbearing potential, you must have a negative urine or blood pregnancy test within 1days prior to having the FDG

PET-CT/MR-PET scans.

- If you have aneurysm clips, metal fragments in the eye, certain types of metal implants or prostheses, a pacemaker or other permanently attached electronic devices that are not marked MRI compatible you may not be able to participate in the MR-PET portion of the study

Patient Participants in Lung MRI as a CT supplement in Infection Surveillance Sub Study Must Not:

Be less than 12 years of age

Have claustrophobia or require sedation to undergo an MRI.

Have an implanted metal object in the body (i.e. aneurysm clips, metal fragments in the eye) that is contraindicated for MRI.

Be pregnant.

Have a body habitus greater than MRI gantry size/weight limit.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00128973